Daclizumab

Characteristics

Humanizirovanne recombinant antibodies IgG_1 (Anti-tas).

Of drugs

The drugs-immunodepressivne. Is receptor antagonist interleikina-2 (SILT-2) : vsokospecificno contact alfa-subjedinica (Tas) vsokoaffinnogo IL1 of Test-2, which is expressed on activated T-kletkah. Oppressing indirect SILT-2 lymphocyte activation inhibits immune response exclusion трансплантата.Достов��рно reduces the frequency gistologicaki proven acute kidney rejection allotransplantata for six months after transplantation (frequency exclusion does not increase after the daklizumaba) and lengthens the time before the first episode of exclusion. Increases 6 and the month survival of patients after трансплантации.Антит��ла daklizumabu to show that 9% of patients, but they do not alter its whey concentrations, effectiveness and �езопасность.Мутагенн ой and carcinogenic activity has been detected. Multiple in / with the introduction of gorillas Cynomolgus doses 1.5; 5.0 and 15 mg / kg / day for 28 days and a one-time across doses 125 mg / kg did not Toksicnosti.c_max manifestations of the patients after allogennouu kidney transplant, after a single dose of 1 mg / kg 21 14 µ g / ml, after 5 infusions (dose of 1 mg / kg) every 14 days - 32 22 µ g / J Full saturation receptors to Test-2 occurs when whey concentrations of 0.5-0.9 μg / ml, indirect suppression SILT-2 biological activity, with the level in plasma 5-10 µ g / J Compliance with the dosing to maintain sufficient concentration of whey for more than 90 days after transplantation. The distribution-0.074 L / kg body weight. T_1/2 in patients with renal allotransplantatom is 270-919 hrs (average 480 hours) and the IgG T_1/2 in humans. Passes through the placenta. Cl system depends on body mass index, age, sex, race, the proteinurii.

Indications

Preventing acute rejection allotransplantata kidneys (in a combination therapy immunosupressivna with ziklosporinom and korticosteroidami).

Restrictions on the use of

The elderly (security and the effectiveness of the people over 65 years of age to be determined, in view of the limited number of transplantations performed by patients of this age group).

Pregnancy and lactation

Perhaps if the effect of therapy outweighs the potential risk to the fetus. At the time of treatment should stop breastfeeding.

Contraindications

Гиперчувствительност ь.

Side-Effects

From the nervous system and sensory organs :> 5% headache, dizziness, insomnia, tremor; 2-5% pricking and stiffness in the legs, depression, anxiety Zrenia.so violation of the circulatory system and blood (blood, gemostaz) :> 5% arterial hypertension or gipotenzia, tachycardia, or bleeding Tromboz.so the respiratory system : > 5%, cough, shortness of breath, swelling of light; 2-5% atelectasis, stagnation and plevralny vpot, hripa, pharyngitis, rhinitis, Gipoccia.so part of the intestine :> 5% nausea, vomiting, constipation or diarrhoea, neuralgia, pain in the abdomen, pain in epigastria; 2-5% flatulence, gastritis, Gemorroy.so the urogenital system :> 5% dizuria, oliguria, edema, necrosis Channel kidney limfocele; 2-5% damage to the kidneys, megacystis, kidney failure, the delay liquid dehydration, gematuria whose Mochi.so the musculoskeletal system :> 5% pain in the bones and muscles, pain in the lower back; 2-5% pain in the Sustawah.so Skin :> 5% deterioration in the regeneration of skin, acne; 2-5% itch, girsutizm, skin rashes, skin, the reactions at the site Wvedenia.prochie :> 5% pain in the chest, fever, weakness; 2-5% : giperglikemia, shivers, anaphylactoidnye reaction.

Specific guidance

Only under the supervision of qualified medical personnel.

Patient interaction

Farmatsevticeski incompatible with the other solution. There were interactions with immunoglobulinom antilimfocitarian, ziklosporinom, korticosteroidami, mofetila mikofenolatom, azatioprinom, ganziklovirom aciclovir, etc.

Overdosing

Overdose signs have been detected.

Precautions

Women of child-bearing age must use adequate contraception during treatment and during the four months after the meeting.

Dosing and Administration

In / in slowly (within 15 min), the peripheral or central suicide. The recommended dose of 1 mg / kg body weight (tentatively concentrate grow 0.9% solution of sodium chloride). First, the introduction of 24 hours before transplantation, the second and subsequent doses (total-5 doses) introduced at intervals of 14 days. Opening a subsequent doses can be used for the planned more than one day in the two sides.

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